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Pharmaceutical Dosage Forms, USP 32 Page Poraneous Compounding of Dosage Forms

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Pharmaceutical Dosage Forms, USP 32 Page Poraneous Compounding of Dosage Forms Pharmacopeial Forum 1260 IN-PROCESS REVISION Vol. 35(5) [Sept.–Oct. 2009] BRIEFING the general principles involved in the manufacture of some of them, particularly on a small scale. Other information that is gi- ven bears on the use of the Pharmacopeial substances in extem- h1151i Pharmaceutical Dosage Forms, USP 32 page poraneous compounding of dosage forms. 663. This general information chapter is being revised in its en- tirety to represent current compendial thinking with respect to official preparations. The proposed revision incorporates con- BIOAVAILABILITY cepts outlined in a Stimuli to the Revision Process article, Devel- opment of a Compendial Taxonomy and Glossary for Bioavailability, or the extent to which the therapeutic constit- Pharmaceutical Dosage Forms, authored by an Ad Hoc Commit- uent of a pharmaceutical dosage form intended for oral or top- tee composed of the chairs of the Pharmaceutical Dosage ical use is available for absorption, is influenced by a variety of Forms Expert Committee, Biopharmaceutics Expert Commit- factors. Among the inherent factors known to affect absorption tee, Nomenclature and Labeling Expert Committee, and the are the method of manufacture or method of compounding; Council of Experts for the revision cycle, 2000—2005, and pub- the particle size and crystal form or polymorph of the drug sub- lished in PF 29(5). The Stimuli article proposed a tiered catego- stance; and the diluents and excipients used in formulating the rization for pharmaceutical dosage forms proceeding from dosage form, including fillers, binders, disintegrating agents, route of administration to physical form and ultimately release lubricants, coatings, solvents, suspending agents, and dyes. Lu- pattern. This proposed general information chapter emphasizes bricants and coatings are foremost among these. The mainte- the second tier of the compendial taxonomy, the physical dos- nance of a demonstrably high degree of bioavailability requires age form, rather than the route of administration, with the in- particular attention to all aspects of production and quality con- tention of avoiding redundancy for dosage forms given by trol that may affect the nature of the finished dosage form. multiple routes. The proposed revision is organized into four sections provid- ing discussion of general considerations, product quality tests, TERMINOLOGY dosage form monographs, and a glossary. General considera- tions include dose uniformity, stability, bioavailability, manufac- Occasionally it is necessary to add solvent to the contents of a ture, and route of administration. The discussion of product container just prior to use, usually because of instability of some quality tests reflects the universally applied as well as dosage drugs in the diluted form. Thus, a solid diluted to yield a suspen- form specific testing that help assure safety and efficacy from sion is called [DRUG] for Suspension; a solid dissolved and dilu- manufacture through shelf life. The dosage form monographs ted to yield a solution is called [DRUG] for Solution; and a provide general descriptions, discussion of general principles of solution or suspension diluted to yield a more dilute form of their manufacturing or compounding, and recommendations the drug is called [DRUG] Oral Concentrate. After dilution, it is for proper use and storage. The glossary is intended to provide important that the drug be homogeneously dispersed before guidance in selection of official names for official articles but administration. also as a resource to provide definitions beyond those used in official names for dosage forms.Theglossaryclearlydistin- guishes preferred from not preferred terminology. AEROSOLS The revised general information chapter presents current concepts relating to the naming of dosage forms. Outdated Pharmaceutical aerosols are products that are packaged un- forms such as elixirs, spirits, tinctures, and syrups are herein re- der pressure and contain therapeutically active ingredients that cognized as solutions. Lotions are defined as emulsions typically are released upon activation of an appropriate valve system. for topical use. While inserts are defined as solid dosage forms They are intended for topical application to the skin as well as for placement within body cavities, suppositories are differenti- local application into the nose (nasal aerosols), mouth (lingual ated as only for placement within the rectum. aerosols), or lungs (inhalation aerosols). These products may be This general information chapter is intended to be supple- fitted with valves enabling either continuous or metered-dose mented by more detailed discussion of characteristics, quality delivery; hence, the terms ‘‘[DRUG] Metered Topical Aerosols,’’ tests, and other considerations based on route of administra- ‘‘[DRUG] Metered Nasal Aerosols,’’ etc. tion. Early drafts of such concepts relating to topical and trans- The term ‘‘aerosol’’ refers to the fine mist of spray that results dermal dosage forms are presented in PF 35(3) [May–June from most pressurized systems. However, the term has been 2009]. Proposed general test chapter h3i Topical and Transder- broadly misapplied to all self-contained pressurized products, mal Drug Products—Product Quality Tests, providing quality test- some of which deliver foams or semisolid fluids. In the case of ing procedures, complements the performance testing Inhalation Aerosols, the particle size of the delivered medication proposed in h725i Topical and Transdermal Drug Products— must be carefully controlled, and the average size of the parti- Product Performance Tests. Additional revision proposals of sim- cles should be under 5 mm. These products are also known as ilar standards for the oral (gastro-intestinal), mucosal, by inha- metered-dose inhalers (MDIs). Other aerosol sprays may con- lation, and by injection routes are planned. tain particles up to several hundred micrometers in diameter. The basic components of an aerosol system are the container, (BPC: W. Brown.) RTS—C69686 the propellant, the concentrate containing the active ingredi- ent(s), the valve, and the actuator. The nature of these compo- nents determines such characteristics as particle size distribution, uniformity of dose for metered valves, delivery rate, wetness and temperature of the spray, spray pattern and Change to read: velocity or plume geometry, foam density, and fluid viscosity. Types of Aerosols h1151i PHARMACEUTICAL Aerosols consist of two-phase (gas and liquid) or three-phase (gas, liquid, and solid or liquid) systems. The two-phase aerosol DOSAGE FORMS consists of a solution of active ingredients in liquefied propel- lant and the vaporized propellant. The solvent is composed of the propellant or a mixture of the propellant and cosolvents Dosage forms are provided for most of the Pharmacopeial such as alcohol, propylene glycol, and polyethylene glycols, drug substances, but the processes for the preparation of many which are often used to enhance the solubility of the active in- of them are, in general, beyond the scope of the Pharmacopeia. gredients. In addition to defining the dosage forms, this section presents In-Process Revision # 2009 The United States Pharmacopeial Convention All Rights Reserved. Pharmacopeial Forum Vol. 35(5) [Sept.–Oct. 2009] IN-PROCESS REVISION 1261 Three-phase systems consist of a suspension or emulsion of Containers the active ingredient(s) in addition to the vaporized propel- lants. A suspension consists of the active ingredient(s) that Aerosol containers usually are made of glass, plastic, or metal, may be dispersed in the propellant system with the aid of suit- or a combination of these materials. Glass containers must be able excipients such as wetting agents and/or solid carriers such precisely engineered to provide the maximum in pressure safe- as talc or colloidal silicas. ty and impact resistance. Plastics may be employed to coat A foam aerosol is an emulsion containing one or more active glass containers for improved safety characteristics, or to coat ingredients, surfactants, aqueous or nonaqueous liquids, and metal containers to improve corrosion resistance and enhance the propellants. If the propellant is in the internal (discontinu- stability of the formulation. Suitable metals include stainless ous) phase (i.e., of the oil-in-water type), a stable foam is dis- steel, aluminum, and tin-plated steel. Extractables or leachables charged; and if the propellant is in the external (continuous) (e.g., drawing oils, cleaning agents, etc.) and particulates on phase (i.e., of the water-in-oil type), a spray or a quick-breaking the internal surfaces of containers should be controlled. foam is discharged. Manufacture Propellants Aerosols are usually prepared by one of two general proces- The propellant supplies the necessary pressure within an aer- ses. In the ‘‘cold-fill’’ process, the concentrate (generally cooled osol system to expel material from the container and, in com- to a temperature below 08) and the refrigerated propellant are bination with other components, to convert the material into measured into open containers (usually chilled). The valve-actu- the desired physical form. Propellants may be broadly classified ator assembly is then crimped onto the container to form a as liquefied or compressed gases having vapor pressures gener- pressure-tight seal. During the interval between propellant ad- ally exceeding atmospheric pressure. Propellants within this dition and crimping, sufficient volatilization of propellant oc- definition include
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